CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
Decompressive cervical spine surgery +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00447343
NCT00447343N/ACompleted

Mapping of the Sensorimotor Cortex in Cervical Myelopathy Using Functional Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy

In Brief

An observational study evaluating Decompressive cervical spine surgery and fMRI and MRS scan for Spinal Cord Diseases. Completed, enrolled 35 participants across 1 site.

Detailed Summary

Decompressive surgery to relieve symptoms of spinal cord compression due to dysfunction, such as arthritis, has proved variable in success. Past research has reported that approximately one-third of surgery patients improved, one-third remained the same and one-third worsened. Currently, there are no reliable tests that can predict the outcome following surgery. We are hoping that this study will change that. Using functional MRI (fMRI), we wish to investigate the relationship between clinical symptoms and the recovery of brain activation following surgery. One can also track the concentrations of different chemicals (metabolites) by using magnetic resonance spectroscopy (MRS). We hypothesize that the recovery of normal brain activation patterns will coincide with clinical improvement. Our objective in this study is to explore the potential role of fMRI as a tool to prognose patients with cervical myelopathy. Twenty-five patients with cervical myelopathy will be imaged using a high-powered (3 Tesla) fMRI scanner before and six months following surgery. In addition, ten healthy controls will be imaged to provide a baseline measure. Both the patient and control groups will complete questionnaires at the time of their scans. These will provide information concerning the subjective experience of the individuals throughout recovery. We will compare brain activation patterns of control and patient groups to investigate how the brain heals following decompressive surgery.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 14, 2007
Enrollment StartSep 1, 2008
Primary CompletionJan 1, 2011
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.3 years ago

Interventions

Decompressive cervical spine surgeryprocedure

Treatment group (25 patients) will undergo decompressive anterior cervical spine surgery Healthy volunteers will ONLY undergo two scans 6 months apart.

fMRI and MRS scanprocedure

A scan pre-op and 6 months post-op.